Regulatory Guidelines and Standards

Alcohol-based hand rubs (ABHR) are regulated by and of interest to many federal and government organizations. The Food & Drug Administration (FDA), Centers for Disease Control (CDC) and the World Health Organization (WHO) are all involved in establishing guidelines for the use of ABHRs in acute care. The Joint Commission also helps set standards for effective infection control programs in healthcare facilities.

FDA Efficacy Testing Requirements

ABHR are regulated in the US by the Food and Drug Administration (FDA). The FDA sets the requirements for them in what is called the Tentative Final Monograph (TFM) and included within the TFM are efficacy testing requirements to be considered a Health Care Personnel Handwash.

CDC - Centers for Disease Control

The CDC is a federal agency in the U.S. Department of Health and Human Services. The Healthcare Infection Control Advisory Committee (HICPAC) advises the CDC and develops evidence-based guidelines for preventing and controlling healthcare-associated infections. The CDC has no regulatory function but is recognized globally as a leading public health agency.

WHO - World Health Organization

The WHO is the directing and coordinating authority for health within the United Nations system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, and monitoring and assessing health trends.

JC National Patient Safety Goal

The Joint Commission is an independent, not-for profit organization which evaluates and accredits healthcare facilities. The Joint Commission National Patient Safety Goal 7 requires compliance with hand hygiene guidelines from either the CDC or the WHO. The Joint Commission’s Center for Transforming Healthcare selected hand hygiene as their first process improvement project.

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Did You Know

Studies have proven that using an alcohol based hand sanitizer as an infection control strategy in a hospital setting reduces infection rates by 36%.¹

1. Use of alcohol hand sanitizer as an infection control strategy in an acute care facility. Hilburn J, et al Am J. Infec Control 2003; 31:109-16

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